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| |  Topical Corticosteroids Plus Pimecrolimus Cream 1% as Safe as Corticosteroids Alone in Severe Paediatric Dermatitis: Presented at AAD By Jill Stein SAN FRANCISCO -- March 9, 2009 -- A regimen that combines topical corticosteroids used in tandem with the nonsteroidal calcineurin inhibitor cream pimecrolimus 1% is as safe as topical corticosteroids alone for treatment of severe paediatric atopic dermatitis (AD). These results, which represent 4-week safety data from a 16-week trial conducted at 65 centres in 5 countries, were reported here on March 7 at the American Academy of Dermatology (AAD) 67th Annual Meeting. Lawrence Eichenfeld, MD, University of California San Diego, San Diego, California, and colleagues presented the safety results in 376 patients who had been randomised to 4 weeks of treatment with pimecrolimus cream plus topical corticosteroids or corresponding vehicle plus topical corticosteroids. Topical corticosteroids are often the first-line treatment for AD, however, their use is limited due to potential adverse effects such as skin atrophy and telangiectasia, the researchers said. In addition, rebound effects are often reported upon cessation of topical corticosteroids after skin clearance. Pimecrolimus does not cause skin atrophy and/or telangiectasia, according to the researchers. Therefore, it is a viable alternative for the treatment of AD in circumstances where extensive use of topical corticosteroids is inadvisable and these agents are reserved for treatment of breakthrough flares. With their study, Dr. Eichenfeld and colleagues aimed to test the safety of concomitant use of pimecrolimus cream 1% plus topical corticosteroids compared with topical corticosteroids plus vehicle in severe paediatric AD. Patients with treatment success, defined as "cleared" or "almost cleared" AD lesions, were entered in the 12-week observational phase. Demographic and baseline disease characteristics were comparable between treatment groups. Analysis of the adverse events of clinical interest -- the primary endpoint of the study -- indicated a trend toward higher incidence of erythematous rash in the pimecrolimus cream 1% group compared with the vehicle group (P = .05). "Erythematous rash" included adverse events that the investigator reported as papular rash. Among the 4 patients reporting erythematous rash, 3 had rash at the application site and all 4 cases were reported to be mild in severity and were suspected to be related to the study medication, according to the investigators. There was no other marked difference between rates of other adverse events of clinical interest, such as infected eczema, herpes simplex infection, or folliculitis. Given the number and the pattern of cases of erythematous rash, the relevance of this finding is questionable, the researchers noted. Overall, these results show that the safety profiles of topical corticosteroids alone and used concomitantly with pimecrolimus cream 1% were comparable, they said. Funding for this study was provided by Novartis.
[Presentation title: Concomitant Use of Topical Corticosteroids and Pimecrolimus Cream 1% in the Treatment of Severe Pediatric Atopic Dermatitis Has a Safety Profile Comparable to Topical Corticosteroids Alone. Abstract P1310]
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